Quality Assurance Manager

The Fertility Partners; Toronto; On-site; CAD 90,000 - 120,000; Full time

Job summary

The Fertility Partners in the Greater Toronto Area seeks a Quality Assurance Manager to advance its enterprise quality program across a network of fertility clinics. Reporting to the CSO, this role will drive standardized QA practices, internal auditing, and continuous improvement throughout the network.

You will lead audits, manage CAPA, and coordinate Health Canada regulatory readiness across multiple sites. Fluency in English and French is highly preferred to support Quebec clinics.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 5 years of QA in regulated health, laboratory, tissue/blood establishment, or pharmaceutical/medical device environments.
• Experience with quality management systems (document control, CAPA, internal audit) in a regulated setting.
• Working knowledge of Health Canada regulatory frameworks (GMP/GTP-equivalent, tissue/reproductive material regulations) or ability to learn quickly.
• Strong audit skills in planning, conducting, and reporting on audits.
• Bilingual English/French strongly preferred, given Quebec clinics in the network.

Responsibilities

• Support integration and optimization of the QMS across network clinics, acting as super-user for onboarding.
• Lead internal audit programs to assess clinic compliance with quality standards and regulations.
• Manage non-conformance, deviation, and CAPA reporting with Legal, tracking trends for the CSO and verifying corrective actions.
• Build regulatory expertise under SSOR and lead clinic audit preparation and Health Canada coordination.
• Support accreditation readiness (Qmentum/Accreditation Canada) through standardized checklists and onsite support.
• Partner with clinic leadership to embed quality practices, deliver QA training, and investigate incidents.
• Contribute to network-wide quality metrics and leadership reporting.

Skills

Quality Assurance

Internal Audits

Regulatory Compliance

GMP/GTP experience

Bilingual English/French

Education

Bachelor's degree in life sciences

Tools

QMS

CAPA management

Internal audit tools

Job description

Reports To: Chief Scientific Officer (CSO)

Location: Greater Toronto Area (multi-site; travel to clinics and HO)

Employment Type: Full-time, permanent

Position Summary

TFP is recruiting a Quality Assurance Manager to advance its enterprise quality program across its network of fertility clinics. Reporting to the Chief Scientific Officer (CSO), this new role will support the implementation of consistent quality management practices, internal auditing, inspection readiness, and continuous quality improvement throughout the network.

Key Responsibilities

• Support integration and optimization of TFP's QMS across network clinics, acting as super-user for clinic-level onboarding and support.
• Lead internal audit programs to assess clinic compliance with quality standards and applicable regulations, including Health Canada and provincial requirements.
• Manage non-conformance, deviation, and CAPA reporting in coordination with Legal, tracking trends for the CSO and verifying corrective action completion.
• Build regulatory expertise under SSOR and progressively lead clinic audit preparation and Health Canada inspection coordination.
• Support accreditation readiness (Qmentum/Accreditation Canada) through standardized checklists and onsite inspection support.
• Partner with clinic leadership and staff to embed quality practices, deliver QA training, and support incident investigations and root-cause analysis.
• Contribute to network-wide quality metrics and reporting for leadership review.

Qualifications

• Bachelor's degree in a life sciences, laboratory science, nursing, or related health discipline (or equivalent experience).
• Minimum 5 years of quality assurance experience in a regulated health, laboratory, tissue/blood establishment, or pharmaceutical/medical device environment.
• Demonstrated experience with quality management systems (document control, CAPA, internal audit) in a regulated setting.
• Working knowledge of Health Canada regulatory frameworks (e.g., GMP/GTP-equivalent, tissue/reproductive material regulations) or a clear ability to acquire this quickly.
• Strong audit skills planning, conducting, and reporting on internal or third-party audits.
• Bilingual (English/French) strongly preferred, given the Quebec clinics in the network.

Preferred

• Direct experience with the Safety of Sperm and Ova Regulations (SSOR), fertility/ART clinics, tissue banking, or blood establishments.
• Experience preparing organizations for regulatory inspections (Health Canada, FDA, or equivalent).
• Recognized QA/quality certification (e.g., CQA, CQE, RQAP-GLP, or equivalent).
• Experience working across a multi-site network or franchise-style clinical organization.